Charges levelled in Reuben data fraud case

Scott Reuben, the influential US anaesthesiologist found last year to have fabricated clinical trial data for 21 published journal articles on pain management after surgery, is facing up to 10 years’ imprisonment and a US$250,000 fine if convicted of healthcare fraud.

The United States Attorney’s Office for the District of Massachusetts, where Reuben was formerly chief of acute pain at Bay State Hospital in Springfield, has charged the anaesthesiologist with one count of fraud relating specifically to a study proposal and contract involving Pfizer’s COX-2 inhibitor analgesic Celebrex (celecoxib).

Documents filed in the US District Court for Massachusetts further note that for many years, “but at least as early as 1999”, Reuben “made proposals to pharmaceutical companies to perform research studies, entered into contracts to perform research as funded by the pharmaceutical companies, purported to perform the research called for by the contract, and published articles in various medical journals based on the purported results of the research, when in fact those studies had not been performed, and therefore the research results reported in the medical journals were false”.

When the extent of Reuben’s fabrications came to light last March, they were described as constituting one of the largest cases ever of academic fraud. According to press reports, though, Reuben has negotiated a relatively lenient sentence with federal prosecutors in exchange for pleading guilty to the charges. For example, the court documents say that, if convicted, Reuben will forfeit property worth at least US$50,000 “that constitutes, or is derived from, proceeds traceable to the commission of the offence”.

The single count of healthcare fraud alleges that Reuben in or around January 2007 “knowingly and willfully executed a scheme and artifice to defraud Pfizer, Inc … in connection with the delivery of and payment for healthcare benefits, items, and services”.

The charge relates to a research proposal made to Pfizer around July 2005 for a 100-patient study on ‘Perioperative Administration of Celecoxib (Celebrex) as a Component of Multimodel Analgesia for Outpatient Anterior Cruciate Ligament Reconstruction Surgery’. Reuben subsequently signed an Independent Research Grant Agreement for the study, under which Pfizer committed to provide a grant of around US$73,512,000 as well as sufficient quantities of Celebrex and placebo for the trial.

Reuben published two articles on the study in the journal Anesthesia & Analgesia, even though he had not enrolled any patients and the study results were “wholly made up”, the court documents pointed out.